Dr. Malamud on Key Data From KATHERINE Study in HER2+ Breast Cancer

Stephen C. Malamud, MD
Published: Wednesday, Mar 20, 2019



Stephen C. Malamud, MD, associate professor, Icahn School of Medicine, Mount Sinai Health System, discusses key data from the KATHERINE study in the treatment of patients with HER2-positive breast cancer.

The goal of the phase III trial, which was presented at the 2018 San Antonio Breast Cancer Symposium, was to evaluate the role of ado-trastuzumab emtansine (T-DM1; Kadcyla) against the gold standard trastuzumab (Herceptin) in patients who had residual disease following neoadjuvant therapy with a HER2-targeted agent. The results were a “runaway,” in favor of T-DM1, Malamud says, in terms of invasive disease-free survival (iDFS) and delaying local and distant recurrences. The antibody-drug conjugate also demonstrated a toxicity profile that can easily be managed.

Three-year iDFS rates were 88.3% with T-DM1 compared with 77% with trastuzumab. Data show that T-DM1 was also associated with a 50% reduction in the risk of invasive disease recurrence or death.

With these data, the field should see a definitive change in the standard of care for patients who do not achieve a pathologic complete response after surgery, Malamud concludes.
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Stephen C. Malamud, MD, associate professor, Icahn School of Medicine, Mount Sinai Health System, discusses key data from the KATHERINE study in the treatment of patients with HER2-positive breast cancer.

The goal of the phase III trial, which was presented at the 2018 San Antonio Breast Cancer Symposium, was to evaluate the role of ado-trastuzumab emtansine (T-DM1; Kadcyla) against the gold standard trastuzumab (Herceptin) in patients who had residual disease following neoadjuvant therapy with a HER2-targeted agent. The results were a “runaway,” in favor of T-DM1, Malamud says, in terms of invasive disease-free survival (iDFS) and delaying local and distant recurrences. The antibody-drug conjugate also demonstrated a toxicity profile that can easily be managed.

Three-year iDFS rates were 88.3% with T-DM1 compared with 77% with trastuzumab. Data show that T-DM1 was also associated with a 50% reduction in the risk of invasive disease recurrence or death.

With these data, the field should see a definitive change in the standard of care for patients who do not achieve a pathologic complete response after surgery, Malamud concludes.



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